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EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE
The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.
Details
| Lead sponsor | Amany Keruakous, MD, MS. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 100 |
| Start date | 2024-12-01 |
| Completion | 2028-05 |
Conditions
- Multiple Myeloma
Interventions
- Lenalidomide
- Maintenance Vitamin D
- No maintenance Vitamin D
Primary outcomes
- To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days] — 120 days
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
Countries
United States